Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000103460
Ethics application status
Approved
Date submitted
8/09/2006
Date registered
31/01/2007
Date last updated
31/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial of a primary care-based electronic screening and brief intervention for hazardous drinking
Scientific title
A randomised controlled trial to evaluate the effects of web-based motivational feedback on hazardous drinking for the prevention of alcohol-related harm in healthy participants
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Harmful alcohol consumption in healthy participants 1597 0
Condition category
Condition code
Public Health 1700 1700 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
B: Screening (The screening involves patients to complete the 10-item Alcohol Use Disorders Identification Test (AUDIT) at a computer in the waiting area which is connected to the Internet. They also answered questions about the largest amount they consumed in a single episode in the last 4 weeks, the duration of the episode, their age, gender, and ethnicity. It takes 3 minutes.), information leaflet (An educational leaflet providing information on the effects of alcohol and recommended upper limits for low-risk consumption) plus assessment of alcohol use, perceptions of peer drinking norms, and problems 4 weeks later. The assessment involves a 14-day retrospective account of drinks per day, the Alcohol Problems Scale - 14 items, the Academic Role Expectations and Alcohol Scale - 5 items, estimates of others' drinking (7 items) and their height and weight. Median completion time is 11 minutes.
C: Web-based motivational intervention (single-dose); including comparison of patient's drinking with age/gender norms and recommended upper limits. This intervention takes 11 minutes to answer the questions (see above) plus the time required to read the feedback, which we estimate to be 3-5 minutes. Overall, total time is approximately 15 minutes.
D: Web-based motivational intervention (multi-dose); as in C, provided at the commencement of the trial, at 6 months and at 12 months. This intervention takes 15 minutes at baseline and a further 10 minutes four weeks later for assessment and feedback.
Intervention code [1] 1354 0
Behaviour
Comparator / control treatment
A: Screening and information leaflet (control). An educational leaflet providing information on the effects of alcohol and recommended upper limits for low-risk consumption. The screening involves patients to complete the 10-item Alcohol Use Disorders Identification Test (AUDIT) at a computer in the waiting area which is connected to the Internet. They also answered questions about the largest amount they consumed in a single episode in the last 4 weeks, the duration of the episode, their age, gender, and ethnicity. It takes 3 minutes.
Control group
Active

Outcomes
Primary outcome [1] 2357 0
Assessment by computer over the Internet of the Quantity and frequency of drinking
Timepoint [1] 2357 0
At 6 and 12 months.
Primary outcome [2] 2358 0
Assessment by computer over the Internet of Binge Drinking.
Timepoint [2] 2358 0
At 6 and 12 months.
Primary outcome [3] 2359 0
Assessment by computer over the Internet of Personal and Academic Problems.
Timepoint [3] 2359 0
At 6 and 12 months.
Primary outcome [4] 2360 0
Assessment by computer over the Internet of the Alcohol Use Disorders Identification Test Score.
Timepoint [4] 2360 0
At 12 months.
Secondary outcome [1] 4112 0
Change in normative perceptions
Timepoint [1] 4112 0
measured at 6 months and 12 months

Eligibility
Key inclusion criteria
Patients of the University of Otago Student Health Service, Sufficient English to understand consent form
Minimum age
17 Years
Maximum age
29 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If too sick or injured to participate

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Research staff involved in the trial were not informed of participants’ group allocation during intervention or follow-up. The generation of the sequence and loading of it into the server database were conducted by off-site staff who were not involved in the implementation of the trial on site, who never came into contact with study participants. Participants were informed that they were participating in a series of surveys about their drinking. Thier perceptions were checked in a pilot study, and found to be consistent with the aim to conceal group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence was generated in Microsoft Excel using the rand function, and this was loaded into the server which administered the intervention.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Subjects were blind. Note: there were no assessors or therapists as such: all done by computer. The intervention, assessment, and analysis may therefore be said to have been conducted blindly.
Phase
Phase 2 / Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/03/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
572
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1843 0
Government body
Name [1] 1843 0
Health Research Council of New Zealand
Country [1] 1843 0
New Zealand
Funding source category [2] 1844 0
Government body
Name [2] 1844 0
Alcohol Advisory Council of New Zealand
Country [2] 1844 0
New Zealand
Primary sponsor type
Individual
Name
Dr Kypros Kypri
Address
Country
Secondary sponsor category [1] 1661 0
None
Name [1] 1661 0
Nil
Address [1] 1661 0
Country [1] 1661 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3445 0
University of Otago Student Health Service.
Ethics committee address [1] 3445 0
Ethics committee country [1] 3445 0
New Zealand
Date submitted for ethics approval [1] 3445 0
Approval date [1] 3445 0
01/02/2002
Ethics approval number [1] 3445 0
02/010.

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27961 0
Address 27961 0
Country 27961 0
Phone 27961 0
Fax 27961 0
Email 27961 0
Contact person for public queries
Name 10543 0
Dr Kypros Kypri
Address 10543 0
School of Medicine and Public Health
University of Newcastle
David Maddison Building
King & Watt Streets
Newcastle NSW 2300
Country 10543 0
Australia
Phone 10543 0
+61 2 49236231
Fax 10543 0
+61 2 49236148
Email 10543 0
[email protected]
Contact person for scientific queries
Name 1471 0
Dr Kypros Kypri
Address 1471 0
School of Medicine and Public Health
University of Newcastle
David Maddison Building
King & Watt Streets
Newcastle NSW 2300
Country 1471 0
Australia
Phone 1471 0
+61 2 49236231
Fax 1471 0
+61 2 49236148
Email 1471 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.